QA Validation Engineer
About The Position
Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will be responsible for change management activities and ownership of site validation program compliance, including ensuring compliance, improving practices, and qualifying/validating new processes, equipment, and systems with company strategic goals as a guide. The role may also serve as a liaison between the Operations group, including manufacturing, packaging, engineering, maintenance, and other functions, and the QA/QC department for day-to-day activities, capital projects, process improvements, and related initiatives.
Requirements
- Strong understanding of pharmaceutical cGMP, industry standards, and regulations to make sound regulatory interpretation, lead and/or conduct investigations, employ logic, and implement decisions from within the Quality Assurance organization
- Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority levels
- Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems
- Utilize teamwork and problem solving skills across all departments and internally to Quality Assurance
- The ability to lead projects in relation to all quality functions including identify issues, initiate successful corrective actions, and completion of all tasks in timely manner
- Bachelor’s degree or higher in relevant scientific/technical field
- Total Combined Years: 4 or more years within industry or Regulatory/Compliance, including project management experience preferred
- Experience in project management
- Must be well organized with a keen attention to detail
- Knowledge of the various state and federal pharmaceutical validation laws and legislations that are enforced from time to time
Responsibilities
- Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility systems
- Schedules, plans, manages and executes studies for cleaning validations
- Schedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocols
- Reviews and approves validation project documentation
- Coordinates and interfaces with the process unit heads, quality and engineering groups to ensure successful project executions
- Leads and coordinates cross-functional teams for project validation
- Priorities, manages and executes multiple projects utilizing the project management methodologies
- Oversees external validation resources
- Supports the development of best and proven validation practices in the validation department based on current industry guidelines and practices
- Authors relevant standard operating procedures for ensuring compliance with the company’s policies
- Supports regulatory submissions and also regulatory agency inspections whenever requested
- Champions continuous improvements in the validation department
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
